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Abstract
A simple, rapid, mass compatible, selective, stability-indicating ultra high performance liquid chromatographic method was developed for the simultaneous estimation of Perindopril (PER), Indapamide (IND) and their potential impurities in a combination drug product. The chromatographic separation was achieved on Agilent SB C18 (3.0 × 50 mm, 1.8 μm) column as the stationary phase and 0.1 % perchloric acid buffer and acetonitrile as the mobile phase components in a gradient elution mode at a flow rate of 0.8 mL/minute. The detection of the compounds were monitored at 215 nm wavelength and the column thermostat at 60°C. The proposed method was validated as per the ICH guidelines for specificity, accuracy, precision, linearity, robustness, and ruggedness. Stress study demonstrates the stability-indicating ability of the analytical method in determining PER, IND, and potential impurities within the same run. Significant degradation was observed for the drug product under acid hydrolysis and oxidative hydrolysis. Critical Method Parameters were evaluated by applying the design of experiment (DoE) principles and robustness of the method was established by proposing operation design space. Hence, this method is suitable for stability testing of the drug product in quality control laboratories.